Hemifacial ParalysisNCT03996525
Electrical Stimulation to Improve Recovery After Peripheral Nerve Injury
A study testing Electrical Stimulation in people with Hemifacial Paralysis and Bell Palsy, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
After nerve injury and facial palsy, many patients have permanent muscle and sensory dysfunction. Electrical stimulation (ES) of injured nerves may speed up axon growth and improve recovery. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Hemifacial Paralysis, Bell Palsy
- What is being tested?
- Electrical Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteCanada
- Study dates
- 16 Sep 2019to 3 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients undergoing unilateral facial reanimation with a two-stage cross-face nerve graft and free gracilis muscle flap transfer who have;
- i) isolated unilateral facial nerve palsy and
- ii) a functioning contralateral facial nerve.
Who cannot join
- Any disorders that may compromise nerve regeneration or muscle function following muscle transfer, including diabetes, polyneuropathy, or myopathy and muscular dystrophy.
- Patients with severe cognitive impairment, which would limit their participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electrical Stimulation to Improve Recovery After Peripheral Nerve Injury - A Randomized Controlled Prospective Study
After nerve injury and facial palsy, many patients have permanent muscle and sensory dysfunction. Electrical stimulation (ES) of injured nerves may speed up axon growth and improve recovery. This study will assess if ES accelerates motor axon regeneration and improves muscle recovery in patients undergoing two-staged facial reanimation for facial palsy.
This study of ES in these patients will investigate:
Read more
- nerve regeneration over long distances; ii) direct evidence of changes in nerve regeneration with nerve samples from the second procedure; and iii) changes in functional outcomes in a patient population with much less variability.
Our study will provide evidence about the effect of ES in improving outcomes in patients with nerve injuries.
- Conditions
- Hemifacial Paralysis, Bell Palsy
- Being tested
- Electrical Stimulation, Sham Treatment
- Keywords
- unilateral facial nerve palsy, facial nerve palsy, facial palsy, facial paralysis, cross facial nerve graft, CFNG, peripheral nerve stimulation, electrical stimulation, e-stim, free muscle transfer, FMT
- Medical subject headings
- Facial Paralysis, Bell Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical StimulationDevice
Two-Stage Facial Reanimation (Standard Practice) with electrical stimulation for one hour at 20Hz (Experimental Procedure).
- Cross-Facial Nerve Graft (CFNG) immediately followed by electrical nerve stimulation proximal to the coaptation site on the donor facial nerve.
- Nine-to-Twelve Months later, Free Muscle Transfer (FMT) followed by electrical nerve stimulation proximal to the coaptation site in the intraoral incision.
Sham TreatmentDevice
Two-Stage Facial Reanimation (Standard Practice) with sham electrical stimulation for one hour (Placebo).
- Cross-Facial Nerve Graft (CFNG) followed by placement of unelectrified electrodes proximal to the coaptation site on the donor facial nerve.
- Free Muscle Transfer (FMT) followed by placement of unelectrified electrodes proximal to the coaptation site in the intraoral incision.
| Study group | Role | What they receive |
|---|---|---|
| Electrical Stimulation | Experimental | Electrical Stimulation
The patient will receive active electrical stimulation. Receives: Device: Electrical Stimulation |
| Sham Treatment | Placebo comparator | No Electrical Stimulation
The patient will receive sham electrical stimulation. Receives: Device: Sham Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pre-Operative Lip Excursion with Smile
FACEGRAM will be used to objectively analyse change in commissure excursion.
Measured: Change from Baseline (Pre-Op) over 2 Years
Change in Myelinated Axon Count
The number of myelinated nerve fibres that regenerate and reach the distal CFNG will be compared between groups.
Measured: Change from Baseline (Pre-Op) to the Final Surgery 1 Year Later
Secondary outcomes (6)
Change in Facial Symmetry
FACEGRAM will be used to objectively analyse smile symmetry.
Measured: Change from Baseline (Pre-Op) over 2 Years
Facial Clinimetric Evaluation (FaCE) Scores
The Facial Clinimetric Evaluation (FaCE) Scale is a patient-report questionnaire assessing facial impairment and disability associated with facial paralysis. The 15-item likert scale questionnaire consists of six domains: i) facial movement, ii) facial comfort, iii) oral function, iv) eye comfort, v) lacrimal control and vi) social function.
Each domain produces its own score, with 1 meaning 'problems all the time' and 5 suggesting 'no problems at all.' The domain scores can then be summed to produce a total score assessing total quality of life with respect to facial paralysis.
Measured: Change from Baseline (Pre-Op) Over 2 Years
Time to Reinnervation
Study participants are requested to monitor their facial movements and record any changes in a daily diary once they first notice facial movement.
Measured: Up to 1 year after the Second Operation (FMT)
Myelin Thickness
Using histomorphometry, Myelin Thickness will be used as a surrogate measure for the rate of axon regeneration.
Measured: Change from Baseline (Pre-Op) to the Final Surgery 1 Year Later
Nerve Fibre Diameter
Using histomorphometry, Nerve Fibre Diameter will be used as a surrogate measure for the rate of axon regeneration.
Measured: Change from Baseline (Pre-Op) to the Final Surgery 1 Year Later
Myelin Thickness/Fibre Diameter Ratio
Using histomorphometry, Myelin Thickness/Fibre Diameter Ratio will be used as a surrogate measure for the rate of axon regeneration.
Measured: Change from Baseline (Pre-Op) to the Final Surgery 1 Year Later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2019
- Study start16 Sep 2019
- Primary completion3 Oct 2022
- Study completion3 Oct 2022
Why it stopped: COVID-19 Pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemifacial ParalysisStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Responsible party
- Principal investigator, Gregory Borschel, MD, The Hospital for Sick Children
- Investigators
- Kristen Davidge, MD, Principal investigator, The Hospital for Sick ChildrenRonald Zuker, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03996525
- Sponsor's protocol ID
- 1000063546
- Status last verified
- Feb 2023
- First submitted
- 20 Jun 2019
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Stimulation to Improve Recovery After Peripheral Nerve Injury - A Randomized Controlled Prospective Study
- ClinicalTrials.gov ID
- NCT03996525
- Acronym / sponsor ID
- 1000063546
- Conditions
- Hemifacial Paralysis, Bell Palsy
- Keywords
- unilateral facial nerve palsy, facial nerve palsy, facial palsy, facial paralysis, cross facial nerve graft, CFNG, peripheral nerve stimulation, electrical stimulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 Pandemic
- Enrolment
- 7 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 3 Oct 2022 (actual)
- Study completion
- 3 Oct 2022 (actual)
- First posted
- 24 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
After nerve injury and facial palsy, many patients have permanent muscle and sensory dysfunction. Electrical stimulation (ES) of injured nerves may speed up axon growth and improve recovery. This study will assess if ES accelerates motor axon regeneration and improves muscle recovery in patients undergoing two-staged facial reanimation for facial palsy.
This study of ES in these patients will investigate:
- nerve regeneration over long distances; ii) direct evidence of changes in nerve regeneration with nerve samples from the second procedure; and iii) changes in functional outcomes in a patient population with much less variability.
Our study will provide evidence about the effect of ES in improving outcomes in patients with nerve injuries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrical Stimulation | Experimental | Device: Electrical StimulationElectrical Stimulation The patient will receive active electrical stimulation. |
| Sham Treatment | Placebo comparator | Device: Sham TreatmentNo Electrical Stimulation The patient will receive sham electrical stimulation. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients undergoing unilateral facial reanimation with a two-stage cross-face nerve graft and free gracilis muscle flap transfer who have;
- i) isolated unilateral facial nerve palsy and
- ii) a functioning contralateral facial nerve.
Key exclusion criteria (2 listed)
- Any disorders that may compromise nerve regeneration or muscle function following muscle transfer, including diabetes, polyneuropathy, or myopathy and muscular dystrophy.
- Patients with severe cognitive impairment, which would limit their participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical StimulationTwo-Stage Facial Reanimation (Standard Practice) with electrical stimulation for one hour at 20Hz (Experimental Procedure). 1. Cross-Facial Nerve Graft (CFNG) immediately followed by electrical nerve stimulation proximal to the coaptation site on the donor facial nerve. 2. Nine-to-Twelve Months later, Free Muscle Transfer (FMT) followed by electrical nerve stimulation proximal to the coaptation site in the intraoral incision. | Device | Electrical Stimulation |
| Sham TreatmentTwo-Stage Facial Reanimation (Standard Practice) with sham electrical stimulation for one hour (Placebo). 1. Cross-Facial Nerve Graft (CFNG) followed by placement of unelectrified electrodes proximal to the coaptation site on the donor facial nerve. 2. Free Muscle Transfer (FMT) followed by placement of unelectrified electrodes proximal to the coaptation site in the intraoral incision. | Device | Sham Treatment |
Primary outcome
Change in Pre-Operative Lip Excursion with Smile
Time frame: Change from Baseline (Pre-Op) over 2 Years
FACEGRAM will be used to objectively analyse change in commissure excursion.
Change in Myelinated Axon Count
Time frame: Change from Baseline (Pre-Op) to the Final Surgery 1 Year Later
The number of myelinated nerve fibres that regenerate and reach the distal CFNG will be compared between groups.
6 secondary outcomes
Change in Facial Symmetry
Time frame: Change from Baseline (Pre-Op) over 2 Years
Facial Clinimetric Evaluation (FaCE) Scores
Time frame: Change from Baseline (Pre-Op) Over 2 Years
Time to Reinnervation
Time frame: Up to 1 year after the Second Operation (FMT)
Myelin Thickness
Time frame: Change from Baseline (Pre-Op) to the Final Surgery 1 Year Later
Nerve Fibre Diameter
Time frame: Change from Baseline (Pre-Op) to the Final Surgery 1 Year Later
Myelin Thickness/Fibre Diameter Ratio
Time frame: Change from Baseline (Pre-Op) to the Final Surgery 1 Year Later
Results and safety
The study was stopped early (reason given: COVID-19 Pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
Related trials for Hemifacial Paralysis
Recruiting
Treatment for "Asymmetric Crying Facies"
Hemifacial Microsomia, Facial Nerve Paralysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristen Davidge, MD principal investigator
The Hospital for Sick Children
Ronald Zuker, MD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical Stimulation in people with Hemifacial Paralysis and Bell Palsy, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID-19 Pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pre-Operative Lip Excursion with Smile (time frame: Change from Baseline (Pre-Op) over 2 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023.